Vasopressor Injection Recalled

Citing a lack of assurance of sterility, SterRx is recalling more than 43,000 bags of epinephrine in 0.9% sodium chloride injection, according to the January 5, 2022, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects the following products, which were distributed throughout the United States:

• epinephrine in 0.9% sodium chloride injection, 2 mg per 250 mL (8 mcg per mL, NDC 70324-027-01), from lot S21257/BXC (no expiration date provided);
• epinephrine in 0.9% sodium chloride injection, 4 mg per 250 mL (16 mcg per mL, NDC 70324-227-01), from lots S21254/BWZ (Exp. 11/22/21), S21263/BXG (Exp. 11/30/21), S21333/BZT (Exp. 1/11/22), and S21398/CCG (Exp. 2/19/22);
• epinephrine in 0.9% sodium chloride injection, 5 mg per 250 mL (20 mcg per mL, NDC 70324-052-01), from lots S21255/BXA (Exp. 1/22/22), S21264/BXH (Exp. 1/29/22), and S21328/BZO (Exp. 3/10/22);
• epinephrine in 0.9% sodium chloride injection, 8 mg per 250 mL (32 mcg per mL, NDC 70324-077-01), from lots S21255/BXA (Exp. 1/22/22), S21264/BXH (Exp. 1/29/22), and S21328/BZO (Exp. 3/10/22); and
• epinephrine in 0.9% sodium chloride injection, 16 mg per 250 mL (64 mcg per mL, NDC 70324-627-01), from lot S21335/BZV (no expiration date provided).

SterRx voluntarily initiated the recall November 12, 2021. On December 29, 2021, the FDA designated the recall Class II. Products affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.

Epinephrine is a prescription vasopressor.